Continuous Infusion of Terlipressin in Septic Shock

Phase 2

Completed

• Conditions: Septic Shock
• Interventions: Drug: Vasopressin; Drug: Terlipressin; Drug: Norepinephrine

• Registration Number: NCT00481572
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.

Detailed Description

Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-06-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-26
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Clinical diagnosis of Septic shock
• vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria

• Pregnancy
• Present cardiac dysfunction
• Present or suspected acute mesenteric ischemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Vasopressin	Vasopressin
1	Terlipressin	Terlipressin
3	Norepinephrine	titrated norepinephrine

Primary Outcome Measures

Name	Time	Method
Systemic and regional hemodynamics	during the first 48 hours from the onset of septic shock

Secondary Outcome Measures

Name	Time	Method
Markers of inflammation,organ functions,adverse effects.	during the first 48 hours from the onset of septic shock

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"; 🇮🇹 Rome, Viale del Policlinico 155, Italy